The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

Device Description

single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

AI/ML Overview

The provided text describes a 510(k) summary for the HDC Corporation's Safe-T-Peel® Safety Needle/Introducer. The document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be found in a clinical trial or a specific standalone performance assessment.

Therefore, many of the requested elements (acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone study, ground truth type, training set size, training set ground truth establishment) cannot be directly extracted from the provided text for a performance study as typically understood for AI/algorithm-based devices.

However, based on the principle of substantial equivalence, the "acceptance criteria" here is that the device performs similarly to the predicate devices, particularly regarding safety features. The "study" proving this comes in the form of comparing the device's characteristics and functionality to those of already approved predicate devices.

Here's an attempt to address the prompt based on the available information, highlighting what can and cannot be provided:

Acceptance Criteria and Study for HDC Corporation's Safe-T-Peel® Safety Needle/Introducer

The provided 510(k) summary focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a performance study with explicit acceptance criteria and quantitative results for device performance against a predefined metric. For a 510(k) submission of this nature, the "acceptance criteria" revolve around demonstrating that the new device has the same intended use, similar technological characteristics, and comparable safety/performance to the predicate devices. The "study" involves a comparative analysis of these attributes.

1. Table of Acceptance Criteria and Reported Device Performance

As a 510(k) submission seeking substantial equivalence for a medical device rather than a software algorithm, explicit "acceptance criteria" in terms of sensitivity, specificity, or similar statistical metrics are not provided in this document. Instead, the acceptance criteria relate to structural and functional similarity to predicate devices, particularly for safety features.

Criteria Category	Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Intended Use	Same primary and secondary intended uses as predicate devices.	"The Safe-T-Peel® Safety Needle Introducer is used to facilitate placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick." "The primary intended use is nearly identical to the primary intended use of Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304), TFX Corporation's TFX Medical Introducer Assembly (K993191), and TFX Corporation's TFX Modical Safety Needle with Introducer (K000665). The secondary intended use (protection against needle stick injury) is nearly identical to that of both the K013304 and K000665 predicate devices."
Technological Characteristics	Similar design and components, especially for the splittable sheath and sharps injury prevention mechanism.	"The Safe-T-Peel® Safety Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191)." "The sharps injury prevention mechanism is essentially identical to the mechanism used in Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304)."
Principle of Operation	Similar method of facilitating catheter placement and mechanism for sharps injury prevention.	"The Safe-T-Peel® Safety Needle/Introducer is substantially equivalent to the previously cleared predicate device (K013304) with sharps injury prevention features because it has the same intended uses, similar principles of operation, similar technological characteristics and similar performance test results."
Safety/Performance	Comparable safety and performance to predicate devices (e.g., in preventing needlestick injuries, material compatibility, functional integrity).	"similar performance test results" (This statement is made, but specific detailed test results are not provided in the summary, as is common for 510(k) where detailed test reports are submitted separately)

2. Sample size used for the test set and the data provenance

Not applicable/provided. This device is a physical medical device, not an AI/algorithm. The "test set" for substantial equivalence is the comparison against the characteristics and performance of the predicate devices. The data provenance would be the design specifications and testing data of the device itself and of the predicate devices, which are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. The concept of "ground truth" established by experts for a test set (as typically used for AI/algorithm evaluation) does not apply directly to this 510(k) summary for a physical medical device. The "truth" here is established by regulatory approval of the predicate devices and the demonstration of equivalence through design and performance testing (not detailed in this summary).

4. Adjudication method for the test set

Not applicable/provided. See explanation for point 3.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical safety needle/introducer, not an AI/algorithm-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical safety needle/introducer.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this device submission, the "ground truth" is effectively the established safety and efficacy of the predicate devices, against which the new device is compared to demonstrate substantial equivalence, based on design features, materials, and functional testing.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of an algorithm.

9. How the ground truth for the training set was established

Not applicable. See explanation for point 8.

Summary

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SEP 2 0 2002

Ko 22099

HDC Corporation's Safe-T-Peel® Safety Needle/Introducer 510(k) Summary

Name of Device	Safe-T-Peel® Safety Needle/Introducer
Common or Usual Name	Safety Needle/Introducer
Classification Names	Catheter, Intravascular (Therapeutic,Short-term less than 30 days) - 21 C.F.R. §880.5200
Product Codes	FOZ

Submitter

HDC Corporation 628 Gibraltar Court Milpitas, CA 95035

Phone: (408) 942-7340 Facsimile: (408) 586-8680 Contact Person: Earl Smart Date Prepared: June 27, 2002June 26, 2002

Predicate Devices

Becton DickinsonInfusion TherapySystems, Inc.	TFX Corporation	TFX Corporation
INTROSYTEAutoguardShieldedIntroducer	TFX MedicalIntroducerAssembly	TFX MedicalSafety Needle withIntroducer
(K013304)	(K993191)	(K000665)

Intended Use

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Substantial Equivalence

All predicate devices presented for comparison with the Safe-T-Peel® Safety Needle/Introducer are single patient, single use, stainless steel needle introducers with splittable sheaths, intended to facilitate the placement of Peripherally Inserted Catheters (PICs). Additionally the Safe-T-Peel® Safetv Needle/Introducer contains a splittable plastic sheath identical to the one used in the TFX Medical Introducer Assembly (K993191).

The Safe-T-Peel® Safety Needle/Introducer is substantially equivalent to the previously cleared predicate device (K013304) with sharps injury prevention features because it has the same intended uses, similar principles of operation, similar technological characteristics and similar performance test results. The primary intended use is nearly identical to the primary intended use of Becton Dickinson's INTROSYTE Autoguard Shiclded Introducer (K013304), TFX Corporation's TFX Medical Introducer Assembly (K993191), and TFX Corporation's TFX Modical Safety Needle with Introducer (K000665). The secondary intended use (protection against needle stick injury) is nearly identical to that of both theK013304 and K000665 predicate devices. The sharps injury prevention mechanism is essentially identical to the mechanism used in Becton Dickinson's INTROSYTE Autoguard Shielded Introducer (K013304).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 0 2002

HDC Corporation C/O Mr. Jonathan S. Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington. D.C. 20004-1109

Re: K022099

Trade/Device Name: Safe-T-Peel® Safety Needle Introducer Regulation Number: 880.5200 and 870.1340 Regulation Name: Intravascular Catheter and Catheter Introducer Regulatory Class: II Product Code: FOZ and DYB Dated: June 27, 2002 Received: June 27, 2002

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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Page 2 – Mr. Kahan

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- 4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Suren Ramo

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number	K
Device Name	Safe-T-Peel Safety Needle Introducer

Indications for Use The Safety T Reel Safety Needle Introducer is used to facilitateThe Safety-T-Peel Safety Needle Introducer is used to facilitate Indications for Use placement of a peripherally inserted intravenous catheter, through the skin into a vein and when used according to the Instructions For Use (IFU) may reduce the risk of an accidental needle stick.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Tallessa Vincenti

Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K022677

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).